FDA.reportPublic FDA data

VOCO Retraction Paste

Primary DI
E22110130
Brand
VOCO Retraction Paste
Company
VOCO GmbH
Model
1013
Catalog number
1013
Device description
Material for the temporary retraction of the marginal gingiva to provide a dry gingival sulcus when the periodontium is healthy prior to, e.g. analogue or digital impressions, cementation of temporary and permanent restorations or preparation of class II and V fillings.
Published
2021-12-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVLCord, Retraction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVLCord, RetractionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213149000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213149000VOCO Retraction PasteVoco GmbH2021-12-09MVL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E22110131PrimaryHIBCC0
E22110130Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Gingival retraction solutionA liquid substance used in dentistry to induce gingival retraction by in situ impregnation of a non-medicated gingival retraction cord. It induces contraction of the upper strata of the free gingiva typically through the action of an astringent agent (e.g., aluminium chloride). This device may also induce a local stasis of gingival exudates and gingival haemorrhages. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius23 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
999-999-9999xxx@xx.xx

Regulatory Flags#

DUNS number
316699578
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E22122661VOCO Profluorid Varnish + BioMin226622662026-05-06
E22122671VOCO Profluorid Varnish + BioMin226722672026-05-06
E22122681VOCO Profluorid Varnish + BioMin226822682026-05-06
E22122691VOCO Profluorid Varnish + BioMin226922692026-05-06
E22122701VOCO Profluorid Varnish + BioMin227022702026-05-06
E22122711VOCO Profluorid Varnish + BioMin227122712026-05-06
E22122721VOCO Profluorid Varnish + BioMin227222722026-05-06
E22122731VOCO Profluorid Varnish + BioMin227322732026-05-06
E22122741VOCO Profluorid Varnish + BioMin227422742026-05-06
E22122761VOCO Profluorid Varnish + BioMin227622762026-05-06
E22122771VOCO Profluorid Varnish + BioMin227722772026-05-06
E22122781VOCO Profluorid Varnish + BioMin227822782026-05-06
E22122791VOCO Profluorid Varnish + BioMin227922792026-05-06
E22163141Grandio disc multicolor631463142026-04-30
E22163151Grandio disc multicolor631563152026-04-30
E22163161Grandio disc multicolor631663162026-04-30
E22163171Grandio disc multicolor631763172026-04-30
E22163181Grandio disc multicolor631863182026-04-30
E22163191Grandio disc multicolor631963192026-04-30
E22163231Grandio disc multicolor632363232026-04-30

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